Clinical trial • Phase I • Infectious Disease
Human papilloma L2 antigen; cyclic di-AMP (adjuvant) for Human papillomavirus (HPV) infection (prophylaxis)
Phase I trial of Human papilloma L2 antigen; cyclic di-AMP (adjuvant) for Human papillomavirus (HPV) infection (prophylaxis).
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Human papillomavirus (HPV) infection (prophylaxis)
- Trial Stage
- Phase I
- Drug Modality
- Vaccine
Key dates
- Initial CTIS Submission Date
- 28-05-2024
- First CTIS Authorization Date
- 06-06-2024
Trial design
open-label, none/not specified-controlled, adaptive Phase I trial across 1 site in Germany.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True, dose-escalation design stated but specific escalation rules, interim analyses, and stopping rules not provided
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 45
Eligibility
Recruits 45 No vulnerable populations selected; trial population: healthy volunteers; consent/assent handling not specified in provided data..
- Vulnerable Population
- No vulnerable populations selected; trial population: healthy volunteers; consent/assent handling not specified in provided data.
Recruitment
- Planned Sample Size
- 45
- Recruitment Window Months
- 41
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 45
Germany
- Earliest CTIS Part Ii Submission Date
- 27-05-2024
- Latest Decision Or Authorization Date
- 06-06-2024
- Processing Time Days
- 10
- Number Of Sites
- 1
- Number Of Participants
- 45
Sites
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Department of Clinical Pharmacology and Pharmacoepidemiology
- Contact Person Name
- Antje Blank
- Contact Person Email
- antje.blank@med.uni-heidelberg.de
- Number Of Participants
- 45
Sponsor
Primary sponsor
- Full Name
- Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- PANHPVAX
- Active Substance
- Human papilloma L2 antigen; cyclic di-AMP (adjuvant)
- Modality
- Vaccine
- First In Human
- Yes
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